BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3528015 · Received December 19, 2013

    Report

    Report Number
    1030489-2013-05136
    Event Type
    Injury
    Date Received
    December 19, 2013
    Date of Event
    October 8, 2013
    Report Date
    December 3, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: AICHMAIR ET AL. SYMPTOMATIC HETEROTOPIC BONE FORMATION AFTER RHBMP-2 UTILIZATION IN LATERAL LUMBAR INTERBODY FUSION. SPINE J. 2013 OCT;13(10):1411-2. (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED IN A PUBLICATION THAT THE PATIENT PRESENTED WITH CHRONIC LOW BACK PAIN (VISUAL ANALOG SCALE: 8¿10/10), MULTI-LEVEL LUMBAR SPINAL STENOSIS, MULTI-LEVEL DEGENERATIVE DISC DISEASE, AND A 35-YEAR-HISTORY OF A CHRONIC RIGHT-SIDED FOOT DROP. AFTER FAILURE OF CONSERVATIVE TREATMENT MEASURES, THE PATIENT UNDERWENT A FOUR-LEVEL STANDALONE LATERAL LUMBAR INTERBODY FUSION (LLIF) PROCEDURE FROM L1¿L5. VERTEBRAL BONE MARROW ASPIRATE, BETA-TRICALCIUM PHOSPHATE, AND RHBMP-2/ACS WERE USED AS BONE GRAFT SUBSTITUTES. AT A POSTOPERATIVE FOLLOW-UP OF 6 MONTHS, THE PATIENT COMPLAINED OF PERSISTENT PAIN IN THE RIGHT LATERAL FLANK AND ILIOSACRAL AREA RADIATING TO THE HIP AS WELL AS THE ANTERIOR GROIN AND THIGH, WHICH WAS NOT PRESENT BEFORE SURGERY. IN ADDITION, THE PATIENT HAD BILATERAL HIP FLEXOR WEAKNESS (4/5). PLAIN RADIOGRAPHY AND COMPUTED TOMOGRAPHY DEPICTED EXTENSIVE HETEROTOPIC OSSIFICATION, WHICH EXPANDED LATERALLY FROM THE LUMBAR SPINE SURROUNDING THE PSOAS MUSCLE ANTERIORLY, MOST PROMINENTLY AT THE L4¿L5 LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664816 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Other